Systems And Procedures Packs Under European MDD Article 12

Download white paper - Systems And Procedures Packs Under MDD Article 12What if you have two medical devices with their own CE marking but they are combined and used together - how would this product be regulated in Europe? The assembly is referred to as a “system” or “procedure pack”. Article 12 of the Medical Devices Directive (MDD) 93/42/EEC defines the conformity assessment necessary to configure individual medical devices into a system.

In this whitepaper, we discuss the regulations and requirements to market you products as a system in Europe. You will learn:

  • What are the requirements of Article 12?
  • What are the system assembler responsibilities?
  • What does it mean to verify mutual compatibility?
  • How to package your system and supply relevant information?
  • How to declare internal control and inspection?

We'll answer all these questions and mor ein this 4-page white paper.

About the Author:
Jennifer Tribbett is a Senior Regulatory Consultant for Emergo, based in Austin, Texas.